1. Field of the Invention
The invention relates to methods for treating mammals with chronic diseases.
2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98.
Autoimmune diseases are related to the disruption of host immune systems. Chronic autoimmune diseases, such as autoimmune hemolytic anemia (henceforth AIHA), immune-mediated hemolytic anemia (henceforth IMHA), inflammatory bowel disease (henceforth IBD), and atopic dermatitis (henceforth AD), typically require consistent treatment with anti-inflammatory drugs such as corticosteroids and immune suppressors such as cyclosporine and azathioprine.
Long term application of these drugs can cause significant drug side effects. As soon as the symptoms are under control, medical doctors and veterinarians often try to reduce dosages or to eliminate entirely the use of these drugs. Unfortunately, the remission of disease makes this approach very challenging. This has created a demand for therapeutics comprised of natural materials with few or no side effects to treat these chronic autoimmune diseases or to reduce the side effects of anti-inflammatory drugs and immune suppressors.
AIHA in humans and IMHA in canines and felines, is an immune disorder caused by antibodies directed against unmodified autologous red cells. AIHA is an increasingly recognized complication of anti-neoplastic therapy in cancer patients, in particular those with chronic lymphocytic leukemia (henceforth CLL). In addition, AIHA is quite often seen in patients with infectious diseases, sometimes in “collagen disorders’ which are systemic autoimmune disorders, and sometimes after organ transplantation. These disorders are acute or chronic diseases.
Inflammatory bowel disease (henceforth IBD) is a general term to describe chronic intestinal inflammation, in which inflammatory cells have spread to the gastrointestinal (henceforth GI) tract. Depending on location and nature of the inflammatory changes, IBD can be classified into two major types—Crohn's disease and ulcerative colitis. Crohn's disease can affect any part of the GI tract with a majority of the cases starting in the ileum. Ulcerative colitis is restricted to the colon and rectum. IBD is considered to be the most probable cause of chronic vomiting and diarrhea in cats (Omi et al., 2008). It is well established that intestinal microflora play an important role in the pathogenesis of IBD (Heilpern and Szilagyi, 2008; Kanauchi et al., 2009). The intestinal microflora is a large bacterial community that colonizes the gut and which affects the physiology and pathology of the host's mucosal immune system (Mamaskos and Kolios, 2008).
The skin is the largest immunologic organ by area and is affected by both external and internal factors, as well as innate and adaptive immune responses. Many skin disorders, such as atopic dermatitis (henceforth AD) are immune mediated. Most of dermatologic diseases are chronic, inflammatory, and proliferative (Fonaciet et al., 2010). Steroids are often used as the first-line treatment of AD, and have been shown to be very effective in improving the symptoms; however, steroids can also cause severe side effects. Other medications such as cyclosporine have been shown to be effective in treating severe AD, and may be used as a substitute for steroids. However, the complications of side effects associated with long-term application can be serious (Haw et al., 2010).
Animals and humans suffering from AD, IBD, AIHA, and IMHA have disruptions of their immune systems and often require long-term steroid and/or immuno-suppressor treatment. A great deal of emphasis has been placed on reducing and alleviating the many severe side effects that these powerful treatments can cause.
The standard treatment in dogs and cats with chronic digestive disorders such as IBD or nonspecific enteropathies (henceforth NPE) is feeding a nutritionally balanced, highly digestible elimination diet. Alternatively, long term administration of multiple drugs, including digestive drugs, antibiotics, immune suppressors, and inflammation suppressors to cats and dogs have been adapted. However, long term, multi-drug regimens cause severe side effects to dogs, cats and humans (Jergens, 1999, Allenspach et al., 2006). It is desirable to reduce the number of drugs used in treatment as soon as symptoms are reduced and the patient is stable. Similar multiple drugs are used in treatment of dogs suffering from chronic diseases such as IMHA (Grundy and Barton, 2001) and such skin diseases as AD. Unfortunately, the recurrence of symptoms is often observed when the amounts of drugs are reduced, especially in the case of reducing corticosteroids such a prednisolone.
Probiotics are beneficial microorganisms that naturally exist in the GI tracts of humans and animals. Oral administration of adequate amounts of probiotics reestablishes the micro-ecosystsms in GI tracts and have been shown to alleviate antibiotic-induced diarrhea (Kaur et al., 2009). Among different probiotics, Pediococcus adidilactici is reported to have better resistance against high temperatures, oxygen exposure, and stomach acid environments than other probiotics (Lin, 2006, Lin and Ishida, 2008). Enhanced immune responses in broiler chicken and rats were noted when the animals were given P. acidilactici alone or in a combination of P. acidilactici and Saccharomyces boulardii (Lee et al., 2007). S. boulardii was also described to enhance immune responses against Clostridium difficle toxin A (Owner et al., 2001). Rats fed with P. acidilactici and S. boulardii had both B-cells and T-cells significantly increased (Lin and Ishida, 2009). When high amounts of live P. acidilactici were administered with antibiotics, substantial numbers of live P. acidilactici were able to survive even under antibiotic treatment. Therefore, administering P. acidilactici and S. boulardii together with antibiotics or other drugs can be a routine treatment for dogs and cats suffering from digestive disorders (Mitztani et al., 2007, Lin and Ishida, 2008).
The use of probiotics as alternative medicines against infectious diseases has been disclosed in U.S. patent application Ser. No. 11/493,859, incorporated herein by reference.
The effects of probiotics on human and animals under environmental or biological changes have been disclosed in U.S. patent application Ser. No. 12/386,285, incorporated herein by reference.
Embodiments of the present application include methods for reducing symptoms in humans and pets such as dogs and cats affected with autoimmune symptoms such as AIHA, IMHA, IBD, NPD, or AD by treating with probiotics P. acidilactici and S. boulardii. Embodiments include methods for reducing the occurrences of IBD or NPD symptoms, AIHA or IMHA symptoms, and AD symptoms when the dosages of drugs are reduced.
The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the drawings.